FDA.report

Gen2

Primary DI
00840343700256
Brand
Gen2
Company
SURGIX MEDICAL LLC
Model
G2E15301
Catalog number
G2E15301
Device description
HOUSE WIRE STRUT GUIDE, 6-1/2''
Published
2022-10-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FZXGuide, Surgical, Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G277G2E153010PreviousHIBCC0
00840343700256PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840343700256008403437002568403437002560840343700256

GMDN Terms

TermDefinition
Nasal depth gauge, reusableA manual instrument designed for introduction into and measurement of the nasal cavities and paranasal sinuses during diagnostic and/or surgical procedures. It typically consists of a hand-held, slender, rod-like metallic device with a fine blunt distal end; the device usually includes rings (e.g., 3, 4, 5 mm) with calibrated diameters at its distal end to perform the measurements. This is a reusable device.

Device Sizes

TypeValueUnit
Length6.5Inch

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
888-247-2477customerservice@surgixmedical.com

Regulatory Flags

DUNS number
080402644
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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